Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201710002664704 Date of Approval: 03/10/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Painless Vaginal Delivery
Official scientific title Effect of the use of dexmedetomidine as a local anesthetic adjuvant in epidural labour analgesia: Randomized controlled study
Brief summary describing the background and objectives of the trial Although cesarean section must be just performed based on medical indications, its rate has been growing worldwide. Fear of childbirth is one of the most important factors causing women especially nulliparous women to be interested in elective cesarean section. The severity of this fear depends on many factors, e.g. personality, history, and experiences. Since this fear is not decreased even after psychological counseling, it is necessary to relieve the pain of normal delivery by offered methods. Labour pain is the result of many complex physiological and psychological interactions. Pain and agony during childbirth are quite unbearable and sometimes beyond description. The pain if not adequately controlled may affect respiratory, cardiovascular, gastrointestinal, urinary and neuroendocrine functions. Pain also reduces uteroplacental blood flow leading to altered fetal homeostasis. Effective analgesia during labour will prevent these avoidable consequences. According to guidelines of the American Society of Anesthesiology (ASA), and American College of Obstetrics and Gynecology (ACOG), epidural analgesia is recommended in painless labour as the most flexible, effective, and least depressing to the central nervous system of the choices available. However obstetric anesthesiologist has occasionally faced with absolute or relative contraindication: women with higher risk for thrombosis, thromboembolism, or receiving anticoagulant therapy. Women also may ask for alternatives to central neuraxial analgesia. Current practice in obstetric analgesia is to combine local anesthetics with adjuvant drugs in order to maintain high efficacy and comfort while reducing individual drug doses and side effects. Alpha 2 (¿ 2) adrenergic receptor agonist, has been widely used and investigated as an analgesic adjuvant for anesthesia and pain therapy, dexmedetomidine belongs to this family but presents with a different and more favorable pharmacokinetics.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Painless Vaginal Delivery,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 12/10/2017
Actual trial start date
Anticipated date of last follow up 11/04/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Computer generated software Sealed closed envelops Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Epidural Bupivacaine alone epidural bupivacaine at a volume of 10 ml and concentration of 0.25% as induction of analgesia. The block was continued by epidural bupivacaine 0.125% at a volume of 10 ml/h From the start of the second stage of labour till delivery of the foetus Epidural labour analgesia 30 Placebo
Experimental Group Epidural bupivacaine and dexmedetomidine Patients in this group will receive epidural bupivacaine 0.25 % at a volume of 10 ml containing 50 ug dexmedetomidine as induction of analgesia. The block was continued by epidural bupivacaine 0.125% From the start of the second stage of labour till delivery of the foetus Epidural labour analgesia 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
-Aged from 21 to 30 years old -With more than 37 weeks of gestation -Vertex presentation -in active normal labour with cervical dilatation more than 3 cm. -Patients refuse of regional anesthesia -Hemodynamically unstable -Known or suspected allergy to the used drugs -With obstetric disorders,pregnancy-induced hypertension, suspected or documented coagulopathy -Body mass index more than 35 kg/m2. 21 Year(s) 30 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 20/09/2017 Tanta Faculty of Medicine Research Ethical Committee
Ethics Committee Address
Street address City Postal code Country
1, Algeish st Tanta 31511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Onset of analgesia - After performing the epidural anlgesia
Secondary Outcome Motor Block Bromage score:- -Before procedure -Then every 15 minutes in the first hour -Then every 30 minutes after the first hour till delivery of the fetus.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University Hospitals 1, Algeish st Tanta 31511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Tanta University Hospitals 1, Algeish st Tanta 31511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Tanta University Hospitals 1, Algeish st Tanta 31511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mohammed Elsayed Afandy Alnady st Tanta 31511 Egypt
Adel Ali Algergawy Moustafa Kamel st Tanta 31511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sameh Abdelkhalik samehabdelkhalik1982@gmail.com 002010029770748 Moheb st
City Postal code Country Position/Affiliation
Tanta 31511 Egypt Lecturer of Anesthesia and Intensive Care- Faculty of Medicine- Tanta University
Role Name Email Phone Street address
Public Enquiries Amr Eid amr_eid_81@yahoo.com 00201277735156 Al Fateh st
City Postal code Country Position/Affiliation
Tanta 31511 Egypt Tanta Sporting Club
Role Name Email Phone Street address
Scientific Enquiries Sohair Soliman sohairsoliman@hotmail.com 00201283929049 Moheb st
City Postal code Country Position/Affiliation
Tanta 31511 Egypt Professor of Anesthesia and Intensive Care- Tanta Faculty of Medicine
REPORTING
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Changes to trial information